BIO-Precision: Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04076917
• Collaborator: (none)
• Enrollment: 84
• Locations: 5
• Actual Duration (Months): 17
• Patients Per Site: 16.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

Detailed Description

BIO-Precision is a post-market study investigating the utility of atrial fibrillation (AF) detection using BIOTRONIK's subcutaneous cardiac rhythm monitor, BIOMONITOR. The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's BIOMONITOR for the detection and confirmation of AF prior to an ablation procedure. Study population includes patients with paroxysmal AF being evaluated for an AF ablation. Holter monitoring for 48 hours will be performed after insertion of the BIOMONITOR but prior to AF ablation. This study will enroll up to 100 subjects, to obtain 60 usable Holter recordings, at 5 study sites within the United States (U.S.). Study subjects will be followed for three months after the completion of a 48 hr Holter monitor.

Study Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: BIO-Precision Study
• Actual Study Start Date: Sep 25, 2019
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 2021

Outcome Measures

Primary Outcome Measures

1. Diagnostic Sensitivity [48 hours]

   The diagnostic sensitivity of the BIOMONITOR will be determined by comparing AF events detected by the BIOMONITOR and 48 hr Holter monitor for each subject. Diagnostic sensitivity is the ability of the BIOMONITOR to correctly identify subjects who have true AF as determined by the Holter monitor. It is calculated as the number of participants with a true BIOMONITOR AF detection divided by the sum of the number of participants with a true BIOMONITOR AF detection and the number of participants with a false negative BIOMONITOR AF detection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meet the indications for subcutaneous cardiac rhythm monitor insertion according to local regulations

• Patient is able to understand the nature of the study and provide written informed consent

• Inserted within the prior 30 days, or scheduled for insertion within 14 days, with BIOTRONIK's most current subcutaneous cardiac rhythm monitor

• Diagnosed with paroxysmal atrial fibrillation and being evaluated for an AF ablation

• Agree to wearing a 48 hr Holter monitor

• Able and willing to complete all study visits at the study site for the study duration

• Able and willing to use a CardioMessenger® and accepts Home Monitoring concept

• Age greater than or equal to 18 years

Exclusion Criteria:

• Patient meets none of the indications for a BIOMONITOR

• Patient is planned to have an ablation prior to BIOMONITOR insertion or 48 hr Holter monitoring visit

• Patient is currently diagnosed with long-standing persistent or permanent AF

• Patient is enrolled in another study that may change or alter the cardiac rhythm that occurs prior to the completion of the Holter

• Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system

• Life expectancy less than 6 months

• Patients reporting pregnancy at the time of enrollment

For patients enrolled after BIOMONITOR insertion:

• R-wave sensing <0.25 mV according to the most recent remote or in-person device interrogation available prior to enrollment

After the pre-Holter observation period but prior to 48 hr Holter monitoring initiation, confirm the absence of the following exclusion criteria based on the remote interrogation collected at the end of the observation period:

• No AF episodes observed or transmitted during pre-Holter observation period

• R-wave sensing <0.25 mV during pre-Holter observation period as reported by the 24 hr mean or mean value since last follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Associates, Inc.	Kissimmee	Florida	United States	34741
2	Florida Cardiology	Winter Park	Florida	United States	32792
3	St. Louis Heart and Vascular	Saint Louis	Missouri	United States	63136
4	The Ohio State University	Columbus	Ohio	United States	43210
5	ProMedica Physicians Cardiology	Toledo	Ohio	United States	43615

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 5, 2019

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT04076917
• Other Study ID Numbers: BIO-Precision
• First Posted: Sep 4, 2019
• Last Update Posted: Apr 5, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	BIOMONITOR III
Arm/Group Description	Participants consented and inserted with a BIOMONITOR III
Period Title: Overall Study
STARTED	84
COMPLETED	15
NOT COMPLETED	69

Baseline Characteristics

Arm/Group Title	BIOMONITOR III
Arm/Group Description	Participants consented and inserted with a BIOMONITOR III
Overall Participants	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	32 38.1%
Male	52 61.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 8.3%
Not Hispanic or Latino	75 89.3%
Unknown or Not Reported	2 2.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 13.1%
White	64 76.2%
More than one race	0 0%
Unknown or Not Reported	8 9.5%
Height (Inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Inches]	67.8 (4.8)
Weight (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	220.9 (53.0)

Outcome Measures

1. Primary Outcome

Title	Diagnostic Sensitivity
Description	The diagnostic sensitivity of the BIOMONITOR will be determined by comparing AF events detected by the BIOMONITOR and 48 hr Holter monitor for each subject. Diagnostic sensitivity is the ability of the BIOMONITOR to correctly identify subjects who have true AF as determined by the Holter monitor. It is calculated as the number of participants with a true BIOMONITOR AF detection divided by the sum of the number of participants with a true BIOMONITOR AF detection and the number of participants with a false negative BIOMONITOR AF detection.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Participants with an evaluable Holter recording who have completed the 48 hr Holter monitor

Arm/Group Title	BIOMONITOR III
Arm/Group Description	Participants consented and inserted with a BIOMONITOR III
Measure Participants	25
Number (95% Confidence Interval) [percentage of participants]	90.9 108.2%

Adverse Events

Time Frame	Insertion through study exit or study termination, an average of 1.7 months, and up to 5.7 months
Adverse Event Reporting Description	Sites were required to report all insertion procedure-related and device-related adverse events. Additionally, sites were required to report all non-procedure non-system related adverse events if any of the following occur and require device removal: (1) Secondary infection, and (2) Other non-elective intervention
Arm/Group Title	BIOMONITOR III
Arm/Group Description	Participants consented and inserted with a BIOMONITOR III
All Cause Mortality
	BIOMONITOR III
	Affected / at Risk (%)	# Events
Total	1/84 (1.2%)
Serious Adverse Events
	BIOMONITOR III
	Affected / at Risk (%)	# Events
Total	1/84 (1.2%)
Infections and infestations
Surgical site infection	1/84 (1.2%)	1
Other (Not Including Serious) Adverse Events
	BIOMONITOR III
	Affected / at Risk (%)	# Events
Total	1/84 (1.2%)
Infections and infestations
Cellulitis at implant site	1/84 (1.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.